Global Food Safety Initiative. Food Safety Auditor Competencies

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1 Global Food Safety Initiative Food Safety Auditor Competencies Edition 1 November 2013

2 Contents Introduction... 3 The GFSI Competence Model... 4 GFSI Food Safety Auditor Competencies in Detail Auditing Skills & Knowledge Plan and organise work effectively Conduct the audit within the agreed timeframe Communicate with auditee personnel at all levels Collect evidence by conducting interviews Collect evidence by observation & inquiry Collect evidence by review of documentation and records Analyse, verify, and consolidate audit evidence and generate findings Prepare written audit reports and follow up and conclusions Technical Skills & Knowledge Food Safety Management (FSM) Requirements for Industry Scopes Al, All, Bl, C, D, El, Ell, Elll, ElV, and L Good Agricultural/Aquaculture Practice (GAP) Requirements for Industry Scopes Al, All, Bl, and Bll Good Manufacturing Practice (GMP) Requirements for Industry Scopes D, El, Ell, Elll, ElV, and L HACCP Requirements for all GFSI Industry Sectors Behavior and Systems Thinking Auditor Conduct and Behaviour Systems Thinking Organizational Behaviour References The Global Food Safety Initiative page 2

3 Introduction Competence: The demonstrated ability to apply knowledge and skills to achieve intended results. GFSI Guidance Document 6 th Edition Part IV, Glossary of Terms As GFSI benchmarked schemes have increased in number and international coverage, the consistency and rigor of the audit process has become increasingly important. Recognising this the GFSI Board established a multi disciplinary Auditor Competence Scheme Committee (ACSC) to manage generic food safety auditor competencies underpinning all GFSI benchmarked schemes, and to oversee a process for assessing competencies and credentialing auditors of GFSI benchmarked standards. The ACSC has developed a competency model for use by all GFSI stakeholders. The competencies have been validated using a professional testing organisation, and revised based on the outcomes of that study (2012). They have also been compared for alignment with the competencies outlined in ISO/DTS (as at July 2013), and those being developed by other international organisations for use by regulatory and commercial food safety auditors. The competencies outlined in this document are those identified as applicable to all post farm gate food manufacturing sectors. The ACSC is currently working on pre farm gate requirements, and will add further competencies as GFSI Technical Working groups publish requirements for other industry scopes (eg brokers, retail). The ACSC is also working on examination and assessment methodologies and options for credentialing auditors of GFSI benchmarked standards. In the meantime, we invite all GFSI stakeholders to review, utilise as appropriate, and comment on the GFSI food safety auditor competencies. Constructive comments are welcome and should be addressed to The references to GFSI scheme scopes in Section 2. Technical Skills and Knowledge relate to the scopes in the GFSI Guidance Document that are illustrated below. For more information, please refer to the GFSI Guidance Document, downloadable as a pdf from the GFSI web site The Global Food Safety Initiative page 3

4 The GFSI Competence Model The GFSI competency model lists the knowledge and skills required to complete the common, generic tasks conducted by all food safety auditor auditing GFSI benchmarked standards. It is based on the key elements identified in part lll of the GFSI Guidance Document, edition 6. GFSI recognises that these are only foundation competencies and scheme specific knowledge and skills are also required, and that additional higher level technical skills can be developed once industry scopes are harmonised across all GFSI benchmarked schemes. The competencies can be summarised as follows: 1. Auditing Skills & Knowledge Auditing competencies common across all management system audits. 1.1 Plan and organise work effectively 1.2 Conduct the audit within the agreed timeframe 1.3 Communicate with auditee personnel at all levels 1.4 Collect evidence by conducting interviews 1.5 Collect evidence by observation and inquiry 1.6 Collect evidence by review of documentation and records 1.7 Analyse, verify and consolidate audit evidence and generate audit findings 1.8 Prepare written audit reports 2. Technical Skills & Knowlege 1. Auditing Skills & Knowledge 3. Behavior & Systems Thinking 2. Technical Skills & Knowledge Knowledge and skills required to audit the key elements identified in the GFSI Guidance Document, edition 6, Part lll: Scheme scopes and key elements 2.1 Food Safety Management (FSM) Requirements for Industry Scopes Al, All, Bl, C, D, El, Ell, Elll, ElV, and L 2.2 Good Agricultural/Aquaculture Practice (GAP) Requirements for Industry Scopes Al, All, Bl, and Bll 2.3 Good Manufacturing Practice (GMP) Requirements for Industry Scopes D, El, Ell, Elll, ElV, and L 2.4 HACCP Requirements for all GFSI Industry Sectors 3. Behavior and Systems Thinking 3.1 Auditor Conduct and Behavior (personal behavior, audit leadership) 3.2 Systems Thinking (critical thinking, problem solving, root cause analysis) 3.3 Organizational Behaviour and Practices The competencies are listed in detail in the following pages. The Global Food Safety Initiative page 4

5 GFSI Food Safety Auditor Competencies in Detail 1. Auditing Skills & Knowledge Task Required Auditor Knowledge Required Auditor Skills 1.1 Plan and organise work effectively terms and definitions applied to auditing of GFSI benchmarked standards the principles of auditing as outlined in ISO :2011, ISO and GFSI scheme management guidelines the objectives and methodology involved in an audit of a GFSI benchmarked standard the key activities involved in a food safety audit program the roles and responsibilities of auditors, Certification Bodies, and auditee personnel management of an audit program. initiating an audit of a GFSI benchmarked standard the purpose and conduct of a document review planning for an on site audit types and forms of management systems and product systems and where GFSI benchmarked standards audits fit within that context organize audit timing based on audit duration establish initial contact with the auditee initiate an audit confirm the audit objectives, scope, and criteria determine the feasibility of the audit plan on site audit activities including evaluation of the audit criteria, (including specific scheme criteria), identification of organizational and functional units, products, and or processes to be audited, and the role and responsibility of the auditor(s) prepare audit plans, checklists, sampling plans, and evidence forms necessary to meet the audit objectives direct and support technical experts (if applicable) develop the audit report format and distribution including the storage and confidentiality of audit reports identify auditee contacts and communicate the audit plan and timetable to the auditee review and/or research the history of the facility The Global Food Safety Initiative page 5

6 1.2 Conduct the audit within the agreed timeframe The timeframe for the audit of a GFSI GFSI benchmarked standard is usually set by the Certification Body. However the auditor must have the knowledge and skills to effectively manage the time within the established timeframe time management tools and techniques within the context of a site audit an audit of a GFSI benchmarked standard as a systematic, independent, and documented process for obtaining relevant audit evidence and evaluating it objectively to determine the extent to which the system criteria are met apply time management tools and techniques that identify the individual tasks during the audit to meet the audit objectives organise audit activities to prioritise matters of significance prepare for the opening meeting, the audit, and the closing meeting outline and direct the involvement of technical experts (if applicable) and auditee contacts within the audit timetable allow time for audit team meetings (if applicable), auditee contact, evidence consolidation and report writing in the audit timetable and to keep others involved on timetable identify strategies to deal with distractions, deviations from the planed evidence path, and/or time wasting without compromising the audit objectives conduct an entry meeting that meets the meeting objectives within the scheduled time frame conduct the audit according to the agreed timetable conduct an exit meeting that meets the objectives within the scheduled time frame agree the timetable for corrective actions and follow up activities dependent on the risk of the non conformance recognize where changes to the audit schedule are needed The Global Food Safety Initiative page 6

7 1.3 Communicate with auditee personnel at all levels interpersonal skills negotiation techniques language, religious, and cultural sensitivities effective verbal and non verbal communication strategies the vocabulary of food safety regulations, standard requirements, industry standards and technical papers, including microbiological terms and names, and chemical terms and names appropriate to a given industry sector objection management techniques conflict management separation of auditing from consulting self awareness of professional and technical limitations apply interpersonal and negotiating skills in the context of an audit of a GFSI benchmarked standard explain the purpose, scope, and methodology of the audit establish a working relationship with the auditee that supports the intent and objectives of the food safety audit communicate with all operational levels in the auditee food business that considers linguistic and technical skills, and the social customs within the business talk to senior management and establish their level of commitment to the GFSI benchmarked standard maintain objectivity during the audit process assess non verbal communications discuss audit findings openly and honestly with auditee personnel, without error or omission explain technical findings at the appropriate management level within the auditee organization present audit findings to auditee and management clearly, concisely, and objectively, citing the evidence for non conformance resolve areas of potential conflict with auditee management, within the context of the audit objectives maintain auditee confidentiality. discuss the audit findings with only the agreed auditee personnel and/or audit client (if appropriate) maintain composure, and avoid arrogance, anger or other negative behaviours cite the evidence for non conformities identify and communicate issues without offering solution The Global Food Safety Initiative page 7

8 1.4 Collect evidence by conducting interviews interview and questioning styles and techniques effective listening techniques understanding of non verbal communications, personal expression, and body language select and interview appropriate staff at all levels within the auditee business to acquire valid audit evidence use appropriate questioning techniques listen to responses, and confirm responses 1.5 Collect evidence by observation & inquiry observation techniques verbal and non verbal behaviours technologies in use to detect or eliminate food safety hazards statistical sampling techniques focussed (targeted) sampling (ie the concept that sampling will not necessarily be totally random and there will not always be time to take a statistically valid sample) identify and prioritise audit activities in the context of a GFSI benchmarked standard and food safety risk identify and evaluate the application of technology for a given purpose observe and analyse personal behaviour and compare to written position descriptions identify problems or areas of concern and investigate to an acceptable level to establish conformity or non conformity apply appropriate sampling techniques to document and record review adapt or modify sampling based on findings 1.6 Collect evidence by review of documentation and records vocabulary and language of food safety auditing The principles and elements of a GFSI benchmarked standard establish the appropriate quantum of relevant, valid data to be reviewed to form a conclusion read, interpret and analyse documents and records contextualise (ie relate the realities of the organisation to the requirements of the standard) The Global Food Safety Initiative page 8

9 1.7 Analyse, verify, and consolidate audit evidence and generate findings As per 1.1, 1.2, 1.3, plus the following additional knowledge requirement: data analysis techniques consolidation of data into meaningful evidence identification of non conformities through objective evidence specifications of non conformities and requirements for corrective action for GFSI benchmarked standards interpret and summarise auditee documentation, technical standards and regulations relating to food safety and good management practice confirm the sufficiency and appropriateness of audit evidence in the context of the requirements and the organisation s food safety management system verify the accuracy of acquired information accurately record audit evidence as it is collected consolidate audit evidence into findings that meet the objectives of the audit and the conformity level of the auditee. prepare levels of non conformance (where applicable) prepare non conformance reports (where appropriate) that accurately explain the objective evidence (ie what was wrong with the system), the level of criticality of the non conformance, the reference to the specific clause of the standard, and the explanation. verbally communicate non conformances as they are observed and at closing meeting without offering solution The Global Food Safety Initiative page 9

10 1.8 Prepare written audit reports and follow up and conclusions written communication techniques knowledge of methods to identify strengths as well as nonconformities and opportunities for improvement negotiation techniques technical terms and definitions for a given industry sector scheme standard and audit template audit template and reporting requirements for specific GFSI benchmarked standards appropriate corrective actions for identified non conformities Certification Body reporting requirements prepare audit conclusions that identify strengths, opportunities for improvement, and non conformities prepare written audit reports that are concise and accurately present the audit findings produce written documents that are easily understood by the intended audience and communicates effectively the actual conditions to someone who was not present during the audit review and confirm the accuracy of written audit reports provide written confirmation of follow up assessment of corrective actions determine the adequacy of corrective actions proposed or taken by the auditee conduct follow up activities according to the agreed timetable evaluate the effectiveness of corrective actions taken by the auditee conduct post audit review, and measure the effectiveness of the audit timetable and its impact on the audit objectives The Global Food Safety Initiative page 10

11 2. Technical Skills & Knowledge 2.1 Food Safety Management (FSM) Requirements for Industry Scopes Al, All, Bl, C, D, El, Ell, Elll, ElV, and L Task Required Auditor Knowledge Required Auditor Skills The following technical competencies are applicable to all the above GFSI industry scopes unless otherwise indicated. Within each set of competencies, the auditor is required to apply the identified skills and knowledge to all industry scopes covered by the task. FSM1 Food safety management system general requirements The standard shall require that the elements of the organisation s Food Safety Management System be documented, implemented, maintained and continually improved. The food safety management system shall: a) identify the processes needed for the food safety management system, b) determine the sequence and interaction of these processes, c) determine the criteria and methods required to ensure the effective operation and control of these processes, d) ensure the availability of information necessary to support the operation and monitoring of these processes, e) measure, monitor and analyse these processes and implement actions necessary to achieve planned results and continuous improvement. (reference Codex Alimentarius HACCP) HACCP knowledge requirements of HACCP AB 1, and HACCP D, EL 1, plus knowledge of: the key elements of a Food Safety Management System for a given industry sector a generic process approach to management Plan/Do/Check/Act (PDCA), the principles of continuous improvement as applied to food safety management and for appropriate industry sector applicable food safety regulations for a given industry sector food safety principles HACCP skills requirements of HACCP AB 1, and HACCP D, EL 1, plus the ability to: contextualise (ie relate the way the organisation has defined it s processes as compared with the requirements of the standard) analyse the organisation s definition of the management processes needed for the food safety management system assess the sequence and interaction of these processes determine the criteria and methods required to ensure the effective operation and control of these processes assess the availability of information and procedures necessary to support the operation and monitoring of these processes assess the measurement and analysis of these processes assess the actions necessary to achieve planned results and continuous improvement FSM 2 Food safety policy The standard shall require the organisation has a clear, concise and documented food safety policy statement and objectives specifying the extent of the organisation s commitment to meet the safety needs of its products. the purpose, objectives, content and application of a food safety policy as defined by the GFSI benchmarked standard assess the effectiveness and implementation of a food safety policy and it s inter relationship with the documented food safety management system within the context of the organisation FSM3 Food safety manual The standard shall require the organisation has a Food Safety Knowledge of the requirements of a documented food safety Ability to assess the appropriateness, coverage, and currency of a The Global Food Safety Initiative page 11

12 Manual or documented system having a scope appropriate to the range of business activities to be covered, including documented procedures or specific reference to them and describing the interaction of the related process steps. management system for a given industry sector appropriate technologies to manage documentation document control systems current industry trends and emerging issues for a given industry sector knowledge of food safety regulations for a given industry sector food safety manual for a given industry sector evaluate the scope of coverage of a facility s food safety manual within the supply chain assess the effective dissemination of food safety documentation within a facility evaluate if work instructions are aligned with the food safety manual evaluate implementation of the food safety manual FSM 4 Management responsibility The standard shall require that the supplier establish a clear organisational structure, which unambiguously defines and documents the job functions, responsibilities and reporting relationships of at least those staff whose activities affect food safety. Knowledge of organisational structures and the inter relationship of job functions regulatory and legal requirements related to organisational structure and location assess the effective implementation of documented job functions relate the observed job functions back to the documented organisational structure and position descriptions review and interpret key performance indicators and food safety measures FSM 5 Management commitment The standard shall require that the organisation s senior management provide evidence of their commitment to establish, implement, maintain and improve the food safety system. Corporate governance, and the role of senior management in leading a food safety management system the legal responsibility for management with regard to food safety food safety objectives and KPIs in the context of the overall business performance access and communicate with senior management assess the commitment of facility management to the implementation and maintenance of food safety practices assess the food safety objectives and key performance indicators (KPIs) in the context of the overall business performance review and interpret organisational performance measures and in particular food safety measures analyse and assess the involvement of senior management in reviewing the food safety management system read and interpret records, including meeting minutes identify deficiencies / trends that demonstrate the lack of management commitment to the food safety system (areas include but are not limited to: training, plant maintenance/ equipment, resources, monitoring, GMPs, operations, prerequisite programs, HACCP, continuous improvement, etc.,) Example: Correlate system The Global Food Safety Initiative page 12

13 deficiencies of the training program to the lack of resources provided by senior management. effectively communicate the lack of management commitment with senior management document the lack of management commitment in the audit reports FSM 6 Management review The standard shall require that the organisation s senior management review the verification of the food safety system, HACCP Plan or HACCP based plans, at planned intervals, to ensure their continuing suitability, adequacy and effectiveness. The HACCP Plan shall also be reviewed in the event of any change that impacts food safety. Such a review shall evaluate the need for changes to the food safety system, including the food safety policy and food safety objectives. Knowledge requirements under FSM 5 Management Commitment, plus knowledge of: management system review procedures, including knowledge of scope, input/output frequency, implementation strategy, organisational structure and inter relationship between positions within the structure. Skills requirements under FSM 5 Management Commitment, plus the ability to: assess the management system review process identify gaps in the management review process FSM 7 Resource management The standard shall require that the organisation s senior management determine and provide, in a timely manner, all the resources needed to implement, maintain and improve the food safety system. Knowledge of the inter relationship of food safety functions with other organisational functions business resources (time, money, and people) required to implement, maintain and improve the food safety system assess the effectiveness and suitability of the resources applied to food safety. Identify gaps in the resources applied to food safety FSM 8 General documentation requirements The standard shall require that documentation procedures are in place to demonstrate compliance with the standard and ensure that all records required to demonstrate the effective operation and control of its processes and its management of food safety are securely stored for a time period required to meet customer or legal requirements, effectively controlled and readily accessible when needed. regulatory, standard and customer requirements for document control and record retention the requirements of food safety record retention for a given industry sector the requirements of food safety documentation in the context of process management, language and literacy levels record security protocols evaluate the document and record control processes that are in place evaluate the security and storage of documents and records ensure the availability and access of food safety documentation to relevant staff identify gaps in available documentation understand and evaluate records FMS AI, All 8.1 General documentation requirements and FMS AI, All 9.1 Specified requirements (animal and fish farming only) species classifications applicable to animal and aquaculture production, evaluate the stock identification processes that are in place The Global Food Safety Initiative page 13

14 The standard shall ensure that the organisation keep comprehensive living stock records. The record will detail current living stock on the farm, an overview of recent living stock transactions and the recent loss situation within a population or living stock production unit. regulatory and customer requirements for living stock records stock language and terminology for a given industry sector tagging, marking or other techniques used for stock identification for a given industry sector record security protocols evaluate the stock control processes that are in place evaluate the security and storage of documents and records FSM 9 Specified requirements The standard shall require that the organisation ensure that, for all inputs to the process, items and services (including utilities, transport and maintenance) that are purchased or provided and have an effect on product safety, documented specifications are prepared, maintained, securely stored and readily accessible when needed. The standard shall require that a specification review process is in place. the food safety inclusions required in raw material, ingredient, packaging material and service specifications for a given input or service the product safety requirements within contracts for process inputs and services (including utilities, transport, and maintenance) read and interpret specifications, associate process and procedure requirements. assess the applicability of contracts identify gaps and omissions in available specifications verify the effective implementation of specifications and contracts FSM 10 Procedures The standard shall require that the organisation establish, implement and maintain detailed procedures and instructions for all processes and operations having an effect on food safety. appropriate technologies to manage documentation components of management processes responsibilities for documentation, update version, definition of documents, documentation management Ability to compare actual operations with documented procedures assess the appropriateness, coverage, and currency of procedures and instructions for a given industry sector assess the effective dissemination of food safety documentation within a facility verify that standard operating procedures (SOPs) and work instructions are being followed FSM 11 Internal audit The standard shall require that the organisation has an internal audit system in place to cover the scope of the food safety system, including the HACCP Plan or the HACCP based plan. internal audit principles and practice food safety verification activities appropriate to specific industry sectors the principles of continuous improvement as applied to food safety management read and interpret an internal audit schedule evaluate the competence of internal auditors evaluate the adequacy of the internal audit based on scope read and review internal audit reports identify gaps in internal audit practices and reports verify that appropriate corrective actions are identified as necessary The Global Food Safety Initiative page 14

15 verify corrective actions taken as a result of internal audits FSM.12 Corrective action The standard shall require that the organisation has procedures for the determination and implementation of corrective action in the event of any significant non conformity relating to food safety. As per FSM 1 Food safety management system general requirements, plus the following knowledge requirements: Knowledge of : the principles and practice of corrective action as applied to food safety management difference between correction, corrective action, and preventative action As per FSM 1 Food safety management system general requirements, plus the following skill requirements assess the availability of information necessary to support the operation and monitoring of the food safety management processes assess the measurement and, analysis of these processes assess the corrective action plans necessary to achieve planned results and continuous improvement and prevent recurrence verify corrections and corrective actions taken FSM 13 Control of non conformity The standard shall require that the organisation has effective processes in place to ensure that any product, which does not conform to food safety requirements, is clearly identified and controlled to prevent unintended use or delivery. These activities shall be defined in a documented procedure that is securely stored and readily accessible when needed. processes required to identify, quarantine, hold, dispose of, or downgrade unsafe product in a given industry sector regulations covering disposition of unsafe product identify the suitability of procedures in place for disposition of non conforming or unsafe product assess the effectiveness of actions taken to deal with nonconforming or unsafe product FSM 14 Product release The standard shall require that the organisation prepare and implement appropriate product release procedures. Knowledge of regulations applicable to product release the objective, structure and content required for a product release procedure in a given industry sector sampling and testing procedures relevant to product safety in a particular industry sector Ability to review and analyse sampling and test procedures for a given product. assess the appropriateness, application, and effectiveness of a product release procedure. FSM.15 Purchasing The standard shall require that the organisation control purchasing processes to ensure that all externally sourced materials and services, which have an effect on food safety, conform to requirements. Where an organisation chooses to outsource any process that may have an effect on food safety, the organisation shall ensure control over such processes. the food safety inclusions required in raw material, ingredient, packaging material and service specifications for a given input or service contract management risk based approved supplier protocols risk based contract manufacturing protocols read and understand the applicability of supplier contracts assess the appropriateness and effectiveness of applied approved supplier protocols identify gaps and omissions in approved supplier protocols verify the effectiveness of the approved supplier program The Global Food Safety Initiative page 15

16 Control of such outsourced processes shall be identified and documented within the food safety system. FSM 16 Supplier performance The standard shall require that the organisation establish, implement and maintain procedures for the evaluation, approval and continued monitoring of suppliers, which have an effect on food safety. The results of evaluations, investigations and follow up actions shall be recorded. As per FSM 15 Purchasing, plus the following knowledge requirements: performance monitoring As per FSM 15 Purchasing, plus the following skill requirements: apply performance monitoring techniques FSM AI, All 16.1, 16.2 Purchasing This requirement applies to animal and fish farming only The standard shall ensure that the organisation has in place specific policies for the procurement of feed from approved, certified sources. The standard shall ensure that the organisation has in place specific policies for the procurement of approved veterinary medicines. FSM 17 Outsourcing The standard shall require that, where an organisation chooses to outsource any process that may affect food safety, the organisation shall ensure control over such processes. Control of such outsourced processes shall be identified, documented and monitored within the food safety management system. FSM 18 Complaint handling The standard shall require that the organisation establish, implement and maintain an effective system for the management of complaints and complaint data to control and correct shortcomings in food safety. specifications for feed stock supplied to particular animal species or aquaculture production inherent hazards and risks associated with feed stock supplied to particular animal species or aquaculture production veterinary medicines applicable to specific animal and aquaculture production, including mrls and withholding periods As per FSM 1 Food safety management system general requirements, plus the following knowledge requirements: contract manufacturing and other services knowledge of outsourcing protocols As per FSM 1 Food safety management system general requirements, plus the following knowledge requirements: regulatory requirements for non conforming product, withdrawal and recall trend analysis read and interpret feed supply contracts read and interpret feed analysis reports assess the effectiveness of feed supply protocols identify gaps in feed supply protocols verify the procedures for purchase of veterinary medicines for a given industry sector. Identify gaps in the procedures for purchase of veterinary medicines for a given industry sector. As per FSM 1 Food safety management system general requirements, plus the following skill requirements: read and ensure implementation of supplier agreements Review and audit conformance of test results Identify gaps and omissions in contract manufacturer procedures verify the effectiveness of procedures in place to monitor contract manufacturers. As per FSM 1 Food safety management system general requirements, plus the following skill requirements: review the customer complaint process assess the effectiveness of actions taken to prioritise and reduce customer complaints The Global Food Safety Initiative page 16

17 evaluate the significance of individual customer complaints as related to food safety assess the willingness of management and staff to correct and improve shortcomings in food safety FSM 19 Serious incident management The standard shall require that the organisation establish, implement and maintain an effective incident management procedure, which is regularly tested for all products it supplies and covers planning for product withdrawal and product recall as required. Industry or trade protocols in place for serious incidents, trade withdrawals, or product recalls Finished stock identification and control processes. assess the effectiveness, communication, and application of traceability, withdrawal and recall procedures; review and analyse records of mock or actual withdrawals and recalls identify gaps in traceability, withdrawal and recall protocols. FMS AI, All 19.1, 19.2 Serious incident management This requirement applies to animal and fish farming only The standard shall ensure that the organisation has the ability to take measures for the containment and quarantine of any living stock found to be infected with a notifiable disease, parasite or condition that would compromise food safety. The standard shall ensure that the organisation has the ability to take measures for the withdrawal and containment of contaminated feedstuffs. notifiable diseases, parasites, antibiotics, chemical use or conditions that would compromise food safety for a given industry sector regulations covering notifiable diseases and specific industry food safety controls epidemiological impact of disease outbreaks from a given industry sector specifications for feed stock supplied to particular animal species or aquaculture production inherent hazards and risks associated with feed stock supplied to particular animal species or aquaculture production regulations governing containment of contaminated feedstuffs risk based withdrawal protocols for contaminated feedstuffs assess the effectiveness, communication, and application of procedures in place for notifiable diseases, parasites or condition that would compromise food safety identify gaps in serious incident protocols for animal and fish farming read and ensure implementation of supplier feed contract procedures read and interpret feed analysis reports review and audit conformance test results assess the appropriateness and effectiveness of feedstuff containment and withdrawal protocols identify gaps and omissions in feed withdrawal protocols verify the effectiveness of the feed withdrawal procedure. FSM 20 Control of measuring and monitoring devices The standard shall require that the organisation identify the measurement of parameters critical to ensure food safety, the measuring and monitoring devices required and methods to assure that the calibration of these measuring and monitoring the parameters critical to ensuring food safety and to meeting regulatory requirements and customer specification for a given industry sector, and measuring and monitoring equipment and devices used assess the appropriateness and effectiveness of devices used to measure food safety parameters review and analyse calibration procedures and records assess the appropriateness and effectiveness of The Global Food Safety Initiative page 17

18 devices is traceable to a recognised standard. to measure food safety parameters for a given industry sector calibration methods for prescribed measuring and monitoring equipment and devices calibration procedures identify gaps in calibration procedures verify the disposition of product assessed using equipment that is out of calibration FSM 21 Food defence The standard shall require that the organisation has a documented risk assessment procedure in place to address food defence risks and establish, implement and maintain a system to reduce or eliminate the identified risks. The system shall cover Good Agricultural Practices or Good Manufacturing Practices and shall be supported by the food safety system. regulations and or industry codes of practice governing food defence, food protection, food security, bioterrorism or sabotage food defence risk management methodologies food defence protocols applicable to particular countries, jurisdictions, and industry sector typical food defence situations assess the effectiveness and application of the risk management process used to determine food defence risk assess the effectiveness, communication, and application of food defence procedures review and analyse records of mock food defence activities identify gaps in food defence procedures FSM 22 Product labelling The standard shall require that the organisation ensure that all product bears information to enable the safe handling, display, storage and preparation and use of the product within the food supply chain or by the consumer. food labelling legislation in the country of origin and the country(s) of destination applicable to a given product group customer or industry codes of practice on labelling assess the effectiveness and application of label approval procedures read product labels and establish the authenticity of information provided verify the accuracy of label information FMS B 23, and DEL 23.1 Traceability The standard shall require that the organisation establish, implement and maintain appropriate procedures and systems to ensure: Identification of any outsourced production, inputs or services related to food safety, Product identification that includes, as a minimum, the name and address of the producer, A record of purchaser and delivery destination for all products supplied. regulatory requirements for non conforming product, trade withdrawal and recall product identification and traceability procedures assess the effectiveness, communication, and application of identification and traceability procedures review records for raw material, packaging, WIP and finished stock to determine traceability identify gaps in identification and traceability procedures review and analyse mock trace results FMS AI, All 23 Traceability This requirement applies to animal and fish farming only The standard shall require that the organisation establish, specifications for feed stock supplied to particular animal species or aquaculture production evaluate the stock identification and traceability procedures that are in place The Global Food Safety Initiative page 18

19 implement and maintain appropriate procedures and systems to ensure: Identification of any outsourced production, inputs or services related to food safety, A complete record of in process material or final product and packaging throughout the production process, A record of purchaser and delivery destination for all animals, fish, and animal or seafood products supplied, Product identification that includes, as a minimum, the origin (producer and country) and the date of production or packing, Input product identification including feed and feed additives that includes, as a minimum, the name and address of the producer, Lot or batch number, Identification of any veterinary medication purchases and treatments, A record of all living stock inputs and outputs, movements on and off site, to either animal or batch, as appropriate to the industry norm for the species. inherent hazards and risks associated with feed stock supplied to particular animal species risk based approved supplier protocols interpret and evaluate stock records read and interpret feed supply contracts read and interpret feed analysis reports assess the appropriateness and effectiveness of stock and feed procurement procedures identify gaps and omissions in stock and feed procurement procedures FMS AI, All, B 24, and DEL 24.1 Analysis of Inputs (e.g. water, feedstuffs,. ice) The standard shall require that the organisation prepare and implement a system to ensure that analysis of inputs critical to the confirmation of food safety is undertaken and that such analyses are performed to standards equivalent to ISO regulatory requirements governing inputs including processing aids, biochemical, feedstuffs, water and gasses hazards and risks associated with inputs for a given industry sector including (but not limited to) processing aids, biochemical, feedstuffs, water and gasses assess the application and effectiveness of specifications and procedures in place to control the safety of inputs review and evaluate analytical records and certificates of analysis identify gaps in procedures in place to control inputs. FMS AII 24.1 Analysis of Inputs (e.g. water, feed stuffs) This requirement applies to fish farming only The standard shall require that the production and storage of ice, where used to store or transport at the point of slaughter, shall not compromise food safety. hazards and risks associated with ice production hazards and risks associated with aquaculture assess the application and effectiveness of procedures in place to control the production, handling, and safety of ice used in transport review and analyse ice production test reports The Global Food Safety Initiative page 19

20 2. Technical Skills & Knowledge (cont d) 2.2 Good Agricultural/Aquaculture Practice (GAP) Requirements for Industry Scopes Al, All, Bl, and Bll A sub group of the ACSC is working on the GAP competencies, due for completion 11/13 The Global Food Safety Initiative page 20

21 2.3 Good Manufacturing Practice (GMP) Requirements for Industry Scopes D, El, Ell, Elll, ElV, and L Task Required Auditor Knowledge Required Auditor Skills Applicable to: D Pre processing of Plant Products; E1 Processing Animal; E2 Processing Plant Products; E3 Processing of Mixed Products; E4 Ambient Stable Products; L Bio chemicals GMP D 1, EL 1 Facility environment & GMP D 2, EL 2 Local environment The standard shall require that the site or facility be located and maintained so as to prevent contamination and enable the production of safe products. The standard shall require that all grounds within the site or facility be maintained to an appropriate standard regulatory requirements relating to food premises standards and industry codes of practice concerning sanitary construction and design of food premises the food safety risks associated with the location and environment, including potential air, water contamination, pest control, etc sector specific risks such as waste management, dust control, and pest management assess the potential or actual food safety contamination risks associated with the site, grounds, external areas, surrounding properties, and process flow evaluate the measures taken by the site to control actual or potential food safety risks due to the site or location identify gaps in the control measures taken by the site to control actual or potential food safety risks due to the site or location GMP D 3, EL 3 Facility design, construction, layout and product flow The standard shall require that premises, site and / or plant shall be designed, constructed and maintained, both the exterior and the interior, to control the risk of product contamination. As per GMP D 1, EL 1, plus the following knowledge requirements: potential contamination sources production processes for a given industry sector preventative and corrective maintenance practices and technologies used for Preventative Maintenance programs As per GMP D 1, EL 1, plus the following skill requirements evaluate the design and construction measures taken by the site to prevent, minimise or eliminate food safety hazards and risks evaluate the application and effectiveness of the site and preventative and corrective maintenance program identify gaps in the site s preventative and corrective maintenance program GMP D 4, EL 4 Fabrication (input and material handling, preparation, product handling, packing and storage areas) The standard shall require that the fabrication of the site, buildings and facilities be suitable for the intended purpose. As per GMP D 1, EL 1, plus the following knowledge requirements: types of materials suitable for construction of food manufacturing and storage facilities impact of detergents and sanitizers on materials used for fabrication of food facilities As per GMP D 1, EL 1, plus the following skill requirements: assess the potential or actual food safety contamination risks associated with the fabrication of food manufacturing and storage facilities identify areas of potential product contamination or crosscontamination caused by building fabrication GMP D 5, EL 5 Equipment The standard shall require that As per GMP D 1, EL 1, and GMP D 4, EL 4, plus the following knowledge requirements: As per GMP D 1, EL 1, and GMP D 4, EL 4, plus the following skill requirements: The Global Food Safety Initiative page 21

22 equipment be suitably designed for the intended purpose and is used and stored so as to minimise food safety risks. regulatory requirements relating to food premises and equipment food safety contamination risks associated with the design and fabrication of food contact equipment assess the potential or actual food safety contamination risks associated with the design and fabrication of food contact equipment identify areas of potential product contamination or crosscontamination caused by food contact equipment. GMP D 6, EL 6 Maintenance The standard shall require that a system of planned maintenance be in place covering all items of equipment, which are critical to product safety. As per GMP D 1, EL 1, and GMP D 3, EL 3, plus the following knowledge requirement: effective preventative and corrective maintenance programs for a given industry sector As per GMP D 1, EL 1, and GMP D 3, EL 3, plus the following skill requirements: evaluate the application and effectiveness of the preventative and corrective maintenance program identify gaps in the site s preventative and corrective maintenance program GMP D 7, EL 7 Staff facilities The standard shall require that staff facilities be designed and operated so as to minimise food safety risks. the risk of pathogen contamination from human contact standards and industry codes of practice concerning sanitary construction and design of food premises specific requirements regarding toilet rooms, locker rooms or change rooms, uniform issue, hand washing facilities, and canteen areas in given industry sectors requirements for high care areas where applicable personal hygiene practices for given industry sectors assess the potential or actual food safety contamination risks associated with the design and condition of staff facilities including toilet rooms, change rooms and canteens evaluate the application and effectiveness of procedures in place to manage food safety risk from staff facilities identify gaps in the site s procedures to manage food safety risk from staff facilities. GMP EL 8 Physical and chemical product contamination risk The standard shall require that appropriate facilities and procedures be in place to control the risk of physical, chemical or biological contamination of product. (sector = category) As per HACCP AB 1, and HACCP D, EL 1), plus the following additional skill requirements: technologies associated with detection of contaminants including metal detectors, X ray, sieves, filters, divert valves calibration requirements for relevant technologies regulatory and product knowledge of chemicals used within a food manufacturing plant including detergents, sanitizers, processing aids, water treatment chemicals, and pest management chemicals management of non conforming product As per HACCP AB 1, and HACCP D, EL 1), plus the following additional skill requirements: assess the potential or actual food safety contamination risks associated with the design, layout, and condition of production processes. assess the application and effectiveness of procedures in place to prevent product contamination evaluate the appropriateness, application, and effectiveness of technologies used to detect contaminants The Global Food Safety Initiative page 22

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